FDA approves first twice-a-year, subcutaneous injection for multiple sclerosis

Key takeaways:

• Genentech announced it received FDA approval of Ocrevus Zunovo for patients with relapsing and primary progressive multiple sclerosis.
• Ocrevus Zunovo is the first twice-a-year subcutaneous injection.

Genentech announced it received FDA approval for Ocrevus Zunovo to treat patients with relapsing and primary progressive multiple sclerosis, according to a company press release.

The release noted Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) is a twice-a-year subcutaneous injection to be administered by a health care professional.

The data that led to the approval is based on the phase 3 OCARINA II study which demonstrated a safety and efficacy profile consistent with the IV formulation. The release noted ocrelizumab & hyaluronidase-ocsq demonstrated suppression of relapse activity and MRI lesions through 48 weeks. In addition, patient-reported outcomes demonstrated more than 92% of patients reported being satisfied or very satisfied with the subcutaneous administration, according to the release.

“Ocrevus Zunovo gives patients and providers another option for receiving Ocrevus, building on a decade of robust safety and efficacy data for Ocrevus in multiple sclerosis,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in the release. “Today’s approval may offer greater flexibility for health care providers and people living with multiple sclerosis, based on their individual treatment needs.”